Karen Cha BA, MA, MBA

Karen Cha is a Regulatory Affairs (RA) consultant with 21 years of broad RA experience including 9 years in Quality Assurance. She has filed over 20 original Investigational New Drug applications (INDs) for various product types, many of those with smaller companies in early development where she led IND efforts covering all areas - nonclinical, CMC and clinical as well as regulatory operations. She has focused on biologics for oncology (monoclonal antibodies and antibody-drug conjugates) for the past 11 years with the last 8 years heading up Regulatory Affairs at the former affiliate of Astellas Pharma, Agensys, Inc. where she filed 7 original INDs for ADC products. Karen holds graduate degrees in Biomedical Science and Business Administration from Boston University.